Metabolic Effects of Second Generation Antipsychotics in Youth, Subprojects 1, 2, and 3

Subprojects 1 and 2

Protocol-based one-time assessment of the association between use of second generation antipsychotics (SGAs) in youth and adverse metabolic effects, including type 2 diabetes and the metabolic syndrome. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

The Mini-Sentinel Operations Center posted this protocol for public comment from September 11, 2013, through September 25, 2013. A revised version was approved for implementation by FDA on November 21, 2013. A log of changes is included in the revised protocol. These projects have been completed; the final project reports were posted on July 31, 2014.

Subproject 3

Protocol-based one-time assessment to determine the average change in body mass index (BMI) z-score among youth initiating monotherapy treatment with olanzapine, quetiapine or risperidone compared to aripiprazole between baseline (treatment initiation) and: (i) 12 weeks (+/- 2 weeks), and (ii) 52 weeks (+/- 8 weeks) in the Mini-Sentinel Distributed Database (MSDD) population. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

The Mini-Sentinel Operations Center posted this final draft protocol for public comment from October 31, 2014, through November 14, 2014. The public comment period is now closed. A revised version was approved for implementation by FDA on January 14, 2016. A log of changes is included in the revised protocol. This project has been completed; the final project report was posted on February 2, 2018.